A Dose Ranging Study to Compare the Safety and Efficacy o... | NCT00219128

Studies
A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren 150mg, 300mg, and 600mg to Placebo in Patients With High Blood Pressure.

NCT00219128

Sponsor

Novartis

Status

Completed

Last Update Posted

Nov 8, 2011Estimated

Enrollment

671Actual

Phase

Phase 3

Conditions

Hypertension

Interventions

aliskiren

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Nov 2004

Primary Completion Date

Jun 2005Actual

Completion Date

Jun 2005Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2011

Last Update Posted Date

Nov 8, 2011Estimated

Description Module

Brief Summary

Evaluate the blood pressure lowering effect of aliskiren 150mg, 300mg and 600mg compared to placebo in patients with essential hypertension

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

671Actual

Name	Type	Description	Arm Group Labels	Other Names
aliskiren	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in systolic blood pressure after 8 weeks
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 4 weeks and 8 weeks
Blood pressure <140/90 mmHg after 4 weeks and 8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Patients with essential hypertension
Patients who are eligible and able to participate in the study

Exclusion Criteria

Severe hypertension
History or evidence of a secondary form of hypertension
History of Hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Pharmaceuticals		East Hanover	New Jersey	07936	United States

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C446481	aliskiren

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided